# Off-label *use.*

> Off-label use in aesthetic medicine: what is licensed (glabella, crow's feet, forehead, armpits) and what is not, legal basis, duty to inform and safety.

- Source: https://www.vivaderm.de/lexicon-off-label-en.html
- Language: en
- Publisher: VIVA DERM, Privatpraxis für ästhetische Medizin, Rosastraße 6a, 45130 Essen, Germany, +49 1520 8367711
- Responsible physician: Katayoun Mostaghimi (Fachärztin für Allgemeinmedizin)
- Updated: 2026-10-05

Use of a licensed medicine outside its officially licensed indication, after medical judgement and specific information. Common in aesthetic medicine.

## A closer look.

Medicines are licensed for specific uses – for botulinum toxin in aesthetics, for example, frown lines, crow's feet and forehead, medically for underarm sweating or migraine. Any use outside this list – such as chin, neck, masseter or bunny lines – is off-label.

Off-label use is permitted in Germany and everyday in medicine; the physician carries increased responsibility. Requirements are scientific experience with the use, a careful benefit-risk assessment and explicit information that the use is outside the licence.

For patients this does not mean 'unsafe': many off-label uses have been established for decades and are described in guidelines. It means the manufacturer takes no liability for this indication and the decision is made consciously together.

This lexicon entry is general information and does not replace the medical consultation required under German law (§ 630e BGB).

## At a glance.

- **Licensed (aesthetics):** glabella, crow's feet, forehead
- **Off-label:** chin, neck, masseter, nose
- **Permitted:** yes, with information
- **Responsibility:** increased, medical

## Frequently asked questions.

**Is off-label dangerous?**

Not as such. It describes licensing status, not safety. Experience with the use is decisive.

**Do I have to sign something?**

The information about the off-label character is documented; you receive it before treatment.

## Related pages.

- [Informed consent](https://www.vivaderm.de/lexicon-aufklaerung-en.html) – Lexicon
- [Masseter](https://www.vivaderm.de/botox-masseter-en.html) – Off-label example
- [Botulinum toxin](https://www.vivaderm.de/botox-en.html) – Treatment

## Sources

- [§ 630e BGB – duty to inform before treatment (German Civil Code)](https://www.gesetze-im-internet.de/bgb/__630e.html)
- [GOÄ – German scale of medical fees (official text)](https://www.gesetze-im-internet.de/go__1982/)
- [§ 11 HWG – ban on before/after images and advertising promises](https://www.gesetze-im-internet.de/heilmwerbg/__11.html)
- [Professional code of the Medical Association North Rhine](https://www.aekno.de/aerzte/berufsordnung)
- [DGBT – German Society for Aesthetic Botulinum Toxin Therapy](https://www.dgbt.de/)
- [AWMF – German clinical practice guidelines](https://www.awmf.org/)

---
This page is general information and does not replace medical consultation and informed consent (§ 630e BGB). No guarantee of results. Prices are guide prices per GOÄ. Quoting with attribution (VIVA DERM, Essen) is expressly permitted.